ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • Assessing support needs of carers in palliative care

    The overall aim of this project is to investigate the extent to which a carer assessment tool of support needs in end of life home care (CSNAT) improves perceived support, carers’ psychological and physical wellbeing, carer burden, bereavement outcomes and the likelihood of the patient achieving their preferred place of death. The CSNAT is a brief tool (14 items on two A5 pages), and is used to elicit carer concerns early, in a systematic way to achieve better outcomes pre and post bereavement. The tool has two sets of items which cover: 1. support that enables the carer to care for the patient at home 2. support for the carer in their caring role

  • Oral Rehydration Solution Orange vs. Apple/Blackcurrant in addition to standard bowel preparation in colonoscopy: a Pilot Study

    This pilot study wishes to investigate whether the consumption of an oral hydration solution (OHS) during bowel preparation will affect the faecal effluent in terms of colour or quality. The investigators will examine whether the endoscopist can detect which colour OHS has been used in conjunction with bowel preparation (if any), and whether the use of an OHS in conjunction with current bowel preparations pre-colonoscopy can reduce the effects of dehydration (ie nausea, dry mouth, headache, lethargy, increased thirst). This may aid in the tolerability of bowel preparation, which in turn may result in better compliance with bowel preparation, with adequate fluid consumption being achieved. The researchers will also investigate whether the inclusion of an OHS has an impact on bowel cleanliness, polyp/adenoma detection, caecal/terminal ileal intubation rate, and time taken to complete the colonoscopy.

  • The PACT Study: Psychosocial Assessment, Care and Treatment of patients with urological and head and neck cancers.

    This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers. Who is it for? You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital. Trial details All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas. Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.

  • What is the efficacy of therapist-guided and self-guided internet-delivered treatment for young adults (18-24) with symptoms of anxiety and depression?

    This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for young adults (18-24) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment. We expect that the guided interventions will result in superior outcomes to the unguided interventions.

  • Taping and exercise for the treatment of exercise related leg pain.

  • Diabetes Prevention Programs Project DP3: Testing the acceptability and effectiveness of different interventions and modalities

    Proposal Aim To compare the effectiveness and cost-effectiveness of several different diabetes prevention programs including face to face groups, phone only interventions and those that use the internet to deliver lifestyle modification programs. Research design Screening, recruitment and referral Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking 40-65 years, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor. Target number of referrals (i.e. participants who are allocated to one of the four programs (see below). IWSML = 200 participants WSML = 200 participants Diabetes Prevention Programs Once eligible participants will be referred to a central point in each ML. The ‘Program Coordinator’ in each ML will contact the eligible participants explain the study, confirm interest and motivation, obtain consent and give them a choice to take up one of the four programs available in each of their ML areas. There will be a slight variation in each ML as follows: Inner West Sydney ML: Get Healthy Service [phone only] Prevent Diabetes Live Life Well [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in PDLLW face to face group program Western Sydney ML: Get Healthy Service [phone only] SHAPE [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in SHAPE program The programs will have to be offered in random order to each participant to avoid a possible bias here. Once the numbers for each arm have been reached then the participant will be told that they only have a choice of what is left. In this research design the PDLLW face-to-face program is the reference group that we will compare the three others to. It has been estimated that a sample size of 100 participants in each arm will be sufficient to detect between 1-1.5kgs weight difference at the 12-month evaluation between groups. The follow up period has been set as short-term evaluation 6-months from entry into the program and medium-term – 12 months from baseline. This allows completion of the intensive intervention 3-month phase and both short-term and medium term effects to be assessed. Evaluation outcomes It is proposed that once participants have been referred and agreed to be in one of the four arms but before they begin one they will be contacted by Computer Assisted Telephone Interviewers from the Boden to assess the main outcomes. Weight/Height Physical Activity Dietary assessment Waist circumference A welcome pack with a letter and tape measure will be sent to participants advising them to have their weight and waist circumference measures ready to report. In addition, sociodemographics and other relevant information will be collected by CATI. Primary outcomes: The primary goals assessed as follows: Weight (self-report) Physical Activity: Active Australia questions at baseline and 12-months collected as part of the CATI. Nutrition: Fat and Fibre index could be measured by CATI or a 3-day non-weighed food diary collected at baseline at the 12-month review. Secondary outcomes: Waist circumference (self-report) General health will be measured using the SF12. CATI to be repeated at 6 and 12 months after baseline.

  • Mobile 'App' to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women

    Premenopausal women are at increased risk of iron deficiency due to iron losses in menstrual blood and increased requirements during pregnancy. Additionally, inadequate consumption of dietary iron or over-consumption of compounds that impede absorption of iron (e.g. phytate) can result in iron requirements not being met. In addition, women who have a low dietary intake of iron and a low iron level are frequently at risk of a low intake of zinc. Rich dietary sources of iron also tend to be rich sources of zinc. Currently very little is known about the zinc status of Australian women. The aim of this study is to investigate the use of technology to improve iron status, by determining if the dietary advice delivered by the mobile apps can 1) increases intake of bioavailable iron and zinc compared to a control "healthy diet" group; and 2) results in a significant improvement in iron and zinc status and markers of cognition, mood and fatigue compared with a control "healthy diet" group. We hypothesise that: The use of a mobile phone app to optimise intakes of bioavailable iron and zinc over a 16-week period in premenopausal women with low serum ferritin will result in: a) higher dietary intake of bioavailable iron and zinc; b) a greater improvement in iron status; c) a greater improvement in cognition, mood (including indicators of depression and anxiety), fatigue and sleep compared to a control "healthy diet" group.

  • Phase III randomised trial of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone (CEOP) chemotherapy regimen & Filgrastim versus standard dose CEOP chemotherapy regimen in patients with non-Hodgkin’s lymphoma

    This study evaluated the effectiveness of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone ifosfamide (CEOP) chemotherapy regime with Filgrastim, and standard dose CEOP chemotherapy regime in patients with non-Hodgkin's lymphoma (NHL). Who was it for? Patients were eligible to join this study if they were aged 16 years or more, had been diagnosed with NHL (Histological types: Follicular large cell (Group D), Diffuse mixed small cleaved and large cell (Group F), Diffuse large cell (Group G) or Large cell immunoblastic (Group H)), and had not received previous chemotherapy or radiation therapy for NHL. Trial details Participants in this trial were randomly (by chance) allocated to one of two treatment groups. Participants in group 1 received a high dose CEOP chemotherapy regime with Filgrastim which involved 1500mg/m2 of Cyclophosphamide intravenously on day 1, 150 mg/m2 of Epirubicin intravenously on day 1, 1.4 mg/m2 (maximum of 2.0mg) of Vincristine intravenously on day 1, 100 mg/day of Prednisolone orally from days 1 to 5, and 5 micrograms/kg/day of Filgrastim subcutaneously from day 2 until Absolute Neutrophil Count was greater than 10 x 109/L for a maximum of 14 days. This treatment regime was repeated every 3 weeks and was administered to participants 6 times. Participants in group 2 received standard dose CEOP which included 750mg/m2 of Cyclophosphamide intravenously on day 1, 75mg/m2 of Epirubicin intravenously on day 1, 1.4mg/m2 (maximum of 2.0 mg) of Vincristine intravenously on day 1, and 100 mg/day of Prednisolone orally from days 1 to 5. Similarly to group 1, this treatment regime was repeated every 3 weeks and was administered to participants 6 times. All participants were assessed prior to treatment, after 3 courses of the treatment, at completion of the 6 courses of the treatment, at 3 months post treatment, at 6 months post treatment and at 5 years post treatment to assess the effectiveness of the treatment regimes.

  • Prevention of avoidable hospital admissions of older people living at home in Western Australia: a pilot randomized control trial.

    There is published evidence for avoidable hospital admission of older people. However no effective intervention has been adopted as routine practice. A pilot randomized controlled trial is proposed for initial evaluation of a complex intervention, comprising multidisciplinary input into the care of older people at risk of hospital admission for unmet need. Older people will be identified by a review of admission records and further described using a set of measures assessing for physical, social and psychological needs. The needs of those assigned to receive the intervention will be reviewed and addressed by a general practitioner supported by a multidisciplinary team. The study will generate data on: 1)Identifying and engaging at-risk patients 2)Operating a multidisciplinary team- including primary care practitioners who are not formally employed in general practice 3)The relevant interventions that are funded by Medicare and the logistics of delivering those interventions 4)The uptake of such interventions by patients 5)Developing the role of GP as care coordinator within a multidisciplinary team structure. This project will address the recommendations of a recent Cochrane review on reducing hospital admissions. The intervention will be developed with reference to published Australia data and the UK Medical Research Council framework for the development and evaluation of complex interventions. This pilot study is a forerunner to a multi-centered, fully powered randomized controlled trial.

  • Prospective Validation Study of the International Classification of Functioning, Disability and Health Score in Crohn’s disease and ulcerative colitis.

    The central hypothesis is that the IBD-DI is an objective measure of disability in IBD that correlates with work absenteeism. The primary objective of the study was to design and validate a numerical scoring system for the IBD-DI to measure IBD disability using standard statistical techniques. Secondary endpoints include identification of the extent of severe disability, correlation of disability with work absenteeism, and identifying predictors of employment status.

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